Vaginal insert

ABSTRACT

A vaginal insert which can be provided in an applicator for the treatment of urinary incontinence in females. The vaginal insert can provide tension-free incontinence treating support perpendicularly to the urethra (i.e., across the urethra).

CROSS REFERENCE TO RELATED APPLICATION

This application claims the benefit of U.S. Provisional Application No.61/984,455 filed Apr. 25, 2014.

BACKGROUND

Urinary incontinence is a problem among females. It is estimated that upto 50% of women occasionally leak urine involuntarily and thatapproximately 25% of women will seek medical advice in order to dealwith the problem. Stress incontinence, the most common type of urinaryincontinence, refers to the involuntary leakage of urine resulting froma rise in abdominal pressure. When involuntary urination occurs, itoften happens because of a rise in pressure in the bladder for whichthere is no compensating counter-pressure from the bladder neck orurethra. This is usually the result of the abnormal descent of thebladder neck and the urethra into a low position and away from theintra-abdominal pressure system. Known as “hypermobility”, this can bethe result of some injury to the support mechanism which normally keepsthe urethra and the bladder neck in a raised position along the backsideof the pubic bone.

The lowering of the bladder neck and the urethra that occur, forexample, when a woman coughs, sneezes, or laughs, can cause involuntaryleakage of urine. While many different factors may contribute to thedevelopment of stress incontinence, it is most prevalent among womenages 35-65 and those who have had multiple vaginal deliveries.

Stress incontinence is both aggravating and unpleasant for women and itcan also be embarrassing. Many women wear sanitary pads in order to dealwith stress incontinence although this is not a real solution to theproblem and it can be very inconvenient and unreliable. Surgicaltreatment may involve, among other things, elevation of the anteriorvaginal wall (Anterior Colporrhaphy), securing the paraurethal tissue tothe periosteum of the pubic bone (Marshall-Marchetti-Krantz operation),or elevation of the paracervical vaginal anterior wall to the Coopersligament (Burch Colpo suspension) in order to elevate the bladder neckabove the level of the pelvic floor and thereby distribute pressureequally to the bladder, the bladder neck, and the mid-urethra. Recently,a procedure known as “TVT” (Tension Free Vaginal Tape) was developed inwhich a mesh tape is implanted underneath the urethra (usuallymid-urethra) creating a hammock on which the urethra may kink during arise in intra-abdominal pressure. However, surgery is only suitable forsevere cases and the majority of women experiencing stress incontinencedoes not need, and certainly would rather avoid, surgical solutions.

One non-surgical treatment involves the use of vaginal inserts that areinserted into the vagina either by a medical practitioner or by thewoman herself. Most vaginal inserts are designed to apply pressureagainst the bladder neck so as to inhibit or completely block the flowof urine through the urethra. One problem with such devices is that theycompletely block the urethra and thus they need to be removed orcollapsed in order to allow the woman to urinate. To overcome thisdrawback vaginal inserts have been developed having specialized shapesthat do not completely block the urethra but these vaginal inserts tendto be large, uncomfortable, and intrusive. They also tend to causeirritation or soreness to the vagina.

Another common shortcoming is that most vaginal inserts also tend to bedifficult, painful or uncomfortable to insert and/or remove. In order tocorrectly inhibit urine flow, the vaginal insert needs to be properlypositioned in the vaginal canal. As a result, a doctor may be requiredto properly position the vaginal insert. In most cases, the vaginalinsert is adapted for remaining in the vagina for a prolonged period oftime (due to the time and expense of requiring a trained medicalprofessional to insert the vaginal insert). However, when positioned inthe vagina for an extended period of time, the vaginal insert may causevaginal infections, pressure ulcers, and/or bleeding.

A woman may desire to insert a vaginal insert herself thereby assertingpersonal control over the insertion and removal of the vaginal insert.To assist with the insertion of the vaginal insert, an applicator, suchas is used for tampon insertion, can be provided to house the vaginalinsert. A shortcoming associated with simply placing the vaginal insertinto an applicator is that the vaginal insert can experience migrationtowards the outlet of the applicator, such as during shipment orstorage. If the vaginal insert migrates too far towards the outlet, thevaginal insert may self-expel from the applicator prematurely.

A vaginal insert for treating urinary incontinence should have a sizeand shape configuration such that it can be comfortable during theinsertion and removal process. A vaginal insert for treating urinaryincontinence also needs to be capable of expanding following insertioninto the vagina and during wear in order to provide efficaciousincontinence protection. There is a need for a vaginal insert fortreating urinary incontinence which can be comfortable to wear in anat-rest state and which can provide incontinence prevention during ahigh stress event. There is a need for a vaginal insert which can beinserted by the woman without the need for a trained medicalprofessional.

There is a need for a vaginal insert which can be provided to a woman inan applicator. There is a need for a vaginal insert which can remain inthe applicator until such a time when the vaginal insert is needed bythe woman.

SUMMARY

In various embodiments, a vaginal insert can have an anchoring element,a supporting element, a node between the anchoring element and thesupporting element, and a first migration reduction feature. In variousembodiments, the first migration reduction feature can be located on afirst supporting arm of the supporting element. In various embodiments,the first migration reduction feature can be located on an applicatorfacing surface of the first supporting arm of the supporting element. Invarious embodiments, the first migration reduction feature can belocated on a non-applicator facing surface of the first supporting armof the supporting element. In various embodiments, the vaginal insertcan further have a second migration reduction feature located on thefirst supporting arm of the supporting element. In various embodiments,the second migration reduction feature can be located on an applicatorfacing surface of the first supporting arm of the supporting element. Invarious embodiments, the second migration reduction feature can belocated on a non-application facing surface of the first supporting armof the supporting element. In various embodiments, the vaginal insertcan further have a second migration reduction feature located on asecond supporting arm of the supporting element. In various embodiments,the second migration reduction feature can be located on an applicatorfacing surface of the second supporting arm of the supporting element.In various embodiments, the second migration reduction feature can belocated on a non-applicator facing surface of the second supporting armof the supporting element. In various embodiments, the first migrationreduction feature can be located on a first anchoring arm of theanchoring element. In various embodiments, the first migration reductionfeature can be located on an applicator facing surface of the firstanchoring arm of the anchoring element. In various embodiments, thefirst migration reduction feature can be located on a non-applicatorfacing surface of the first anchoring arm of the anchoring element.

An array of vaginal inserts can have a first vaginal insert comprisingan anchoring element, a supporting element, a node between the anchoringelement and the supporting element, a first migration reduction featureand a Shore A hardness; a second vaginal insert comprising an anchoringelement, a supporting element, a node between the anchoring element andthe supporting element, a first migration reduction feature and a ShoreA hardness; wherein the second vaginal insert can differ from the firstvaginal insert in at least one of the Shore A hardness or the migrationreduction feature. In various embodiments, the Shore A hardness of thesecond vaginal insert can differ from the Shore A hardness of the firstvaginal insert. In various embodiments, the first migration reductionfeature of the second vaginal insert can differ from the first migrationreduction feature of the first vaginal insert. In various embodiments,the first migration reduction feature of the first vaginal insert can belocated on a first supporting arm of the supporting element of the firstvaginal insert and the first migration reduction feature of the secondvaginal insert can be located on a first supporting arm of thesupporting element of the second vaginal insert. In various embodiments,the first migration reduction feature of the first vaginal insert can belocated on an applicator facing surface of the first supporting arm ofthe first vaginal insert and the first migration reduction feature ofthe second vaginal insert can be located on a non-applicator facingsurface of the first supporting arm of the second vaginal insert.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of an exemplary embodiment of a vaginalinsert.

FIGS. 2-3 are perspective views of exemplary embodiments of a core.

FIGS. 4-6 are cross-sectional views of exemplary embodiments of thesupporting arms of a core.

FIG. 7 is a perspective view of an exemplary embodiment of a core.

FIG. 8 is a plan view of an exemplary embodiment of a possiblerelationship of the supporting arms of a core to the longitudinal axisof the core.

FIG. 9 is a table showing exemplary performance ranges for medialdeflection and horizontal rotation (left/right from central axis), inaccordance with an exemplary embodiment of a core.

FIG. 10 is a perspective view of an exemplary embodiment of anapplicator for a vaginal insert.

FIG. 11 is a cross-sectional view of the applicator of FIG. 10 takenalong line A-A.

FIG. 12 is a perspective view of the applicator of FIG. 10.

FIG. 13 is a side view of an exemplary embodiment of the component partsof a product package for a vaginal insert.

FIGS. 14A-14C are a series of charts illustrating exemplary corespecifications.

FIG. 15 is a vaginal insert performance graph correlating force exertedto core size, diameter and hardness.

FIG. 16 is a table showing performance characteristics for exemplarybasic core configurations.

FIG. 17A is a perspective view of an exemplary embodiment of a core.

FIG. 17B is a side view of the core of FIG. 17A.

FIG. 17C is a cross-sectional view of the core of 17B taken along lineA-A.

FIG. 17D is a close-up view of Area B of FIG. 17C.

FIG. 18A is a perspective view of an exemplary embodiment of a core.

FIG. 18B is a side view of the core of FIG. 18A.

FIG. 18C is a cross-sectional view of the core of FIG. 18B taken alongline A-A.

FIG. 18D is a cross-sectional view of the core of FIG. 18C taken alongline B-B.

FIG. 18E is a close-up view of Area C of the core of FIG. 18C.

FIG. 19A is a perspective view of an exemplary embodiment of a core.

FIG. 19B is a side view of the core of FIG. 19A.

FIG. 19C is a bottom view of the core of FIG. 19A.

FIG. 19D is a cross-sectional view of the core of FIG. 19B taken alongline A-A.

FIG. 19E is a cross-sectional view of the core of FIG. 19D taken alongline B-B.

FIG. 19F is a close-up view of Area C of the core of FIG. 19D.

DETAILED DESCRIPTION

The present disclosure is generally directed towards a vaginal insertwhich can be provided in an applicator for the treatment of urinaryincontinence in females. The vaginal insert can provide tension-freeincontinence treating support perpendicularly to the urethra (i.e.,across the urethra). It should also be noted that for some women, thedescribed vaginal inserts can also be used as a treatment or part of atreatment for prolapse.

In various embodiments, the vaginal insert can be adapted to be stablein the vagina without significant longitudinal and/or rotationalmovement within the vagina. For example, supporting and anchoring armsof the vaginal insert can be designed to resist longitudinal movementwithin the vagina. As another example, the tips of the supporting and/oranchoring arms can be designed to resist rotational motion by workingwith the natural behavior of the vaginal wall, for example, by beingsized and/or shaped to induce the vaginal wall to at least partiallyenvelope the tip, thereby preventing rotational movement. Stability canalso be enhanced by using the supporting and/or anchoring arms toprovide contact between the vaginal insert and multiple points locatedspatially around the vaginal insert on the vaginal wall. In anembodiment, proper support-rendering positioning of the vaginal insertcan be considered to be where two supporting arms position themselvesone on each side of the urethra while at least one other supporting armprovides opposing force to the vaginal insert when the two supportingarms are subjected to force from the urethra during high-stress eventsthat cause the urethra to drop in the vagina.

In various embodiments, the vaginal insert can be adapted to bedisposable, worn only for a relatively short period of time and thendiscarded and replaced with a new vaginal insert (if needed).Alternatively, the vaginal insert can be recycled for use by sterilizingit between uses. The vaginal insert can be simple and easy to use andcan be inserted in the same user-friendly manner that a tampon isinserted into the vagina during menstruation, for example by using anapplicator. In an embodiment, the vaginal insert can be inserted in anyorientation since the vaginal insert can naturally migrate into acorrect treatment position as a result of the vaginal insert geometry.The vaginal insert can be small, exemplary sizes described below,comfortable, and once inserted, the woman need not think about it againuntil it is removed. As with insertion, removal can be accomplished in asimilar manner as a tampon, such as by pulling on a removal element.

In various embodiments, the vaginal insert can include a core and aremoval element. In various embodiments, the vaginal insert can includea core, a cover, and a removal element. Each of these components will bedescribed in more detail below. An example of a vaginal insert 10 havinga core 12, a cover 14, and a removal element 16 can be seen in FIG. 1.

Referring to FIG. 2, a perspective view of an exemplary embodiment of acore 12 for a vaginal insert 10 (illustrated in FIG. 1) for treatingurinary incontinence is illustrated. For ease of description, the core12 can be arranged around a longitudinal axis 24 and divided into threebasic elements. A top section 18, inside the dashed box, can be providedwhich can serve as the “anchoring” element for stabilizing the vaginalinsert 10 within the vagina. There can be at least one of three types ofanchoring: axial anchoring which can act in the direction along thecentral axis of the vagina, radial anchoring which can act side-to-sideor substantially perpendicular to the central axis of the vagina and/orrotational anchoring which will be described in more detail below. In anembodiment, the anchoring element 18 does not apply significant pressureto the wearer's vagina and/or urethra, which can thereby result inenhanced comfort. A bottom section 20, inside the dashed box, can beprovided which can serve as the “supporting” element for generatingsupport. In various embodiments, support can be generated at asub-urethral location, for example mid-urethra. Alternatively,additionally, and/or optionally, support can be generated at the bladderneck. In various embodiments, the supporting element 20 can provide atleast one type of anchoring, described above, to help anchor the vaginalinsert 10 in position within the vagina. In various embodiments, theroles of anchoring 18 and supporting 20 elements can be switched orshared. In an embodiment, the anchoring 18 and supporting 20 elements ofthe core 12 can function as an internal support structure for a cover 14(such as illustrated in FIG. 1).

In an embodiment, an intermediate section can be provided which can actas a “node” 22 and which can connect anchoring 18 and supporting 20elements. The node 22 of core 12 can have a length which can be a smallportion of the overall length of the core 12. In various embodiments,the length of the node 22 can be less than about 15, 20 or 30% of theentire length of the core 12. In various embodiments, a node 22 having ashort length relative to the entire length of the core 12 can allow formore flexibility in varying the stiffness, the comfort, and the size ofthe core 12 when compared with a same length core 12 with a longer node22.

Various design aspects of the core 12 can encourage stability of thevaginal insert 10 in the vagina, including: the longitudinal design ofthe core 12 which can incorporate anchoring arms 26 adapted to preventmovement of the vaginal insert 10 deeper into the vagina and/orsupporting arms 28 adapted to prevent movement of the vaginal insert 10towards the entrance to the vagina; specially adapted arm tips, such astips 30 and 32, which can resist rotational movement of the vaginalinsert 10 as they can be at least partially enveloped by the vaginalwall; an overall design which can take advantage of the vaginal tentingphenomenon; and, a multi-dimensional aspect which can allow variousarms, 26 and/or 28, of the core 12 to contact multiple and/or opposingvaginal surfaces concurrently.

In an exemplary embodiment, the anchoring element 18 and the supportingelement 20 can each have four arms, 26 and 28, respectively. In such anexemplary embodiment, two arms, 26 and 28, of each of the anchoring 18and supporting 20 elements, respectively, can generally exert pressuretowards the anterior vaginal wall and two arms, 26 and 28, of each ofthe anchoring 18 and supporting 20 elements, respectively, can generallyexert pressure towards the posterior vaginal wall adjacent the bowels.The distal part of the urethra extends into the vagina forming a recessbetween the urethral bulge and the vaginal wall. The arms, 26 and/or 28,which exert pressure anteriorly can fit within these natural recesses oneither side of the urethra. In various embodiments, the anchoringelement 18 and the supporting element 20 can each have more or lessarms, 26 and 28, respectively. For example, the anchoring element 18could have more anchoring arms 26 if there is concern about unwantedmovement of the vaginal insert 10.

Supporting arms 28 can cause elevation of the tissues around theurethra, optionally mid-urethra and/or bladder neck thereby acting as ahammock. This hammock can support the urethra in a tension free manner.In a woman who leaks urine during a stress event (e.g., when abdominalpressure rises during coughing, sneezing, etc.), the urethra sags downbut meets the hammock in its mid-part. The meeting of the urethra andthe hammock can cause an elevation of the intra-urethral pressure withresultant urinary continence.

In an embodiment, anchoring arms 26 can force the vaginal insert 10 toremain in situ within the vagina, unable to substantially move inwardsor outwards of the vagina, or to rotate within the vagina. One reasonthat this can occur can be as a result of the tendency of vaginal wallsto collapse and form an occluded lumen. The arms, 26 and/or 28, of thecore 12 can cause “tenting” of the vaginal walls on top of the arms withresultant sagging of the vaginal walls around the core 12, which canthereby stabilize the core 12. Additionally, in various embodiments,anchoring arms 26 can be flexible and/or elastic and/or resilient. Thisflexibility can enhance the anchoring arms 26 ability to prevent motionof the vaginal insert 10 further into the vagina. As force strives toexert itself on the vaginal insert 10 and move the vaginal insert 10further into the vagina, the flexible anchoring arms 26 can tend tospread apart. This spreading action of the anchoring arms 26 canincrease the friction between the vaginal insert 10 and the vaginalwall, thereby preventing movement further into the vagina. While theanchoring arms 26 can be flexible, it should be noted that they can berigid enough and/or can be configured to spread to prevent unwantedmotion of the vaginal insert 10 towards the entrance of the vagina. Inan embodiment, the anchoring arms 26 can be rigid but the node 22 can beflexible allowing the node 22 to provide flexible anchoring support.Movement towards the vaginal opening can also be resisted by thesupporting arms 28 which tend to widen radially when pulled outwardly.These features work with the tenting behavior of the vaginal walls whichalso helps to maintain the vaginal device 10 in place.

Referring to FIG. 2, the anchoring arms 26 can have tips 30 and thesupporting arms 28 can have tips 32. In various embodiments, the tips 30of the anchoring arms 26 can be rounded or spherical in nature, toprovide smooth surfaces (i.e., no corners or points) for the tenting ofthe vaginal wall. In various embodiments, the tips 32 of the supportingarms 28 and/or corners of core 12 can be blunted by a beveled edge alongthe anchoring arms 26 and supporting arms 28 and at the tips 32, such asshown in FIGS. 2 and 3. In various embodiments, the tips 32 can beslightly rounded and/or have a beveled edge. In an embodiment, thebeveled edge of the supporting arms 28 can reduce the overallcircumference of the core 12, relative to a completely spherical crosssection, when it is in a compressed mode for packaging within anapplicator. The difference between a core 12 with a beveledcross-section and a core 12 with a spherical cross-section can be seenin FIGS. 4 and 5. FIG. 6 illustrates a vaginal insert with a beveledcross-section in an applicator 40.

Also illustrated in FIG. 3 is a channel 34 which can transect the core12, whereby core 12 can be “held” during manufacturing and/or assemblyof the core 12 by placing a rod through channel 34. In an embodiment,channel 34 can be circular in shape. In an embodiment, channel 34 can bequadrilateral shaped. As illustrated in FIG. 6, the channel 34 can beaccessible through the quadrilateral shaped tunnel 36 created by thebeveled edges of supporting arms 28 when compressed for packaging in anapplicator 40. In an embodiment, channel 34 can be no bigger incircumference and/or dimension than tunnel 36.

In various embodiments, cores 12 of all sizes can have arms, bothanchoring 26 and supporting 28 arms, which can be the same length. Insuch embodiments, the core 12 can be symmetrical about the longitudinalaxis 24 of the core 12 as well as symmetrical about the lateral axis ofthe core 12 wherein the lateral axis of the core 12 can be located atthe midpoint of the longitudinal axis 24 of the core 12. In suchembodiments, the node 22 can be located at the midpoint of thelongitudinal axis 24. In various embodiments, cores 12 of all sizes canhave the same total length when completely compressed inwardly. Anexample of an inwardly compressed core 12 can be seen in FIG. 7. In anembodiment, anchoring arms 26 can be shorter than the supporting arms28. In such an embodiment, the longitudinal length of the anchoringelement 18 can be shorter than the longitudinal length of the supportingelement 20 when the core 12 has been completely inwardly compressed. Insuch an embodiment, the node 22 is not necessarily located at themidpoint of the longitudinal axis 24. In such an embodiment, the core 12may be symmetrical about the longitudinal axis 24, however, the core 12is not necessarily symmetrical about a lateral axis which can be locatedat the midpoint of the longitudinal axis 24. In an embodiment, anchoringarms 26 can be a consistent size in a line-up of different sizes ofcores 12 even though the supporting arms 28 may vary in size and/orperformance. Anchoring arms 26 can be the same size, in variousembodiments, to ease manufacturing considerations. In variousembodiments, the anchoring arms 26 of the core 12 can operateindependently, relative to the longitudinal axis of the vagina, from thesupporting arms 28.

In various embodiments, the difference between sizes of cores 12 can bethe resting angle at which supporting arms 28 protrude outwardlyrelative to the longitudinal axis 24 of the core 12. In variousembodiments, “larger” size cores 12 can have a larger radial spreadangle of supporting arms 28, hence they can be “shorter” when put nextto a smaller size core 12 (i.e., a core 12 which does not radiallyspread its supporting arms 28 as much). One potential advantage for sucha design can be that all cores 12, no matter the radial spread angle,can be inserted into one size of an applicator 40.

In an embodiment, the flexibility of various components of the core 12of a vaginal insert 10 can be designed both for function and for comfortto the user. In various embodiments, the core 12 of a vaginal insert 10can be designed with at least one of four aspects of flexibility whichcan assist in accomplishing these goals of function and comfort. Forexample, node 22 of core 12 can enable flexibility between the anchoringelement 18 and the supporting element 20, which can enable the vaginalinsert 10 to adjust to the arch structure of the vagina, as well as toadjust to any position taken by the wearer (e.g., standing, sitting,flexion, etc.) during daily activity. By being able to flex at the node22, pressure exerted on the vaginal wall can be reduced in relation to avaginal insert 10 that does not flex at the node 22.

Another flexibility aspect of the core 12 can relate to providingefficacy and comfort across varying vaginal planes, for example wherethe arms, 26 and/or 28, are adapted to contact the vaginal wall atvarying locations and/or angles of incidence, relative to each other,away from the longitudinal axis 24, such as shown in FIG. 8, which canallow the core 12 of the vaginal insert 10 to be adaptable to varyingvaginal topography/geometries by rotating either left or right from thecentral axis of each arm.

Another related aspect of flexibility can involve the ability of each ofthe arms, 26 and/or 28, to perform medial flexion, wherein each arm, 26and/or 28, can be flexible towards the longitudinal axis 24 whencompressed by the vaginal wall, enabling the adjustment of the vaginalinsert 10 to various vaginal diameters.

A fourth flexibility aspect can be the feature that each arm, 26 and/or28, can operate individually, for example, each arm, 26 and/or 28, beingable to twist clockwise and/or counterclockwise around its own axisallowing the core 12 of the vaginal insert 10 to overcome vaginalstructural variability from one point of contact to the next.

It should be noted that in various embodiments, at least one of thesefour featured aspects of flexibility can allow the core 12 of thevaginal insert 10 to render effective support regardless of vaginaldimension, vaginal shape, vaginal depth and/or through multiple planes.

FIG. 9 is a table showing exemplary performance ranges for medialdeflection (distance the tip of an arm or arms travel toward thelongitudinal axis 24 of the core 12) and horizontal rotation (left/rightmovement perpendicular to longitudinal axis 24), in accordance with anexemplary embodiment of a core 12. Numbers shown are in millimeters. Itshould be understood that horizontal rotation means rotation in axesperpendicular to the longitudinal axis of the vagina, particularly“right” and “left” when viewing the vagina in the longitudinal axisextending from the vaginal opening to the cervix. The ranges shown inFIG. 9 are amounts in mm that each arm could deviate from its naturalposition relative to the longitudinal axis 24 of the core 12. Regardingmedial deflection, it should be noted that when an arm is deflectedmedially, there is most often a corresponding arm on the other side ofthe core 12 which is also deflected medially (but maybe not the sameamount), therefore in an embodiment, medial deflection numbers (in mm)are divided by two in order to approximate medial deflection for asingle arm. It should also be noted that the numbers for medialdeflection in the table in FIG. 9 represent the full amount ofdeflection for a single arm assuming the corresponding arm does not moveat all. In addition, in some embodiments, the maximum amount of medialdeflection is dictated by two opposing arms contacting each other,preventing further medial deflection. In various embodiments, theminimum core 12 diameter that can be achieved is 12 mm, with each armrepresenting a 6 mm portion of that total.

In various embodiments, the core 12 can be made in a plurality of sizesand/or made to exhibit specific performance characteristics, such asradial expansion of the supporting arms 28. In various embodiments, thediameter of a radially expanded anchoring element 18 can range fromabout 30 to about 33 mm. In various embodiments, the diameter of aradially expanded supporting element 20 can range from about 34 or 41 mmto about 50, 51, or 52 mm. In various embodiments, the core 12 can havea length in an expanded configuration from about 34, 35, 36, 37, 38 or39 mm to about 40, 41, 42, 43, 44, 45, or 46 mm. In various embodiments,the core 12 can also be made of different materials and/or materialsexhibiting different performance characteristics, such as, for example,hardness. In various embodiments, the core 12 can be constructed of amaterial or materials which can exhibit a Shore A hardness of 30-80. Invarious embodiments, core 12 can be manufactured to exhibit Shore Ahardness, including, but not limited to, 40, 50 or 70.

In various embodiments, the core 12 can be constructed from a singlepiece (Monoblock). In various embodiments, the core 12 can have ananchoring element 18 and a supporting element 20 which can be providedas separate pieces (bi-polar) which can be attached to form the core 12.In various embodiments, each element, supporting 20 or anchoring 18, canbe constructed of two or more pieces.

Referring to FIG. 1, a perspective view of a core 12 enclosed within acover 14 provided with a removal element 16 is illustrated, inaccordance with an exemplary embodiment of the vaginal insert 10. Cover14 can be optionally any of the covers described in PCT/IL2004/000433;PCT/IL2005/000304; PCT/IL2005/000303; PCT/IL2006/000346;PCT/IL2007/000893; PCT/IL2008/001292; U.S. Provisional PatentApplication No. 60/719,422; U.S. Provisional Patent Application No.60/762,059; and, U.S. Provisional Patent Application No. 60/960,492.

In various embodiments, the cover 14 can be smooth. In variousembodiments, the cover 14 can be formed from woven or non-wovenmaterial. Woven material can include, but is not limited to, textilefabrics which can be made from rayon, cotton, polyolefins, or othersynthetic yarns. The synthetics can be either staple or continuousfilaments. Non-woven materials can include, but are not limited to,spunbond, bonded carded webs, and hydroentangled webs. In variousembodiments, the cover 14 can be constructed from a spunbond non-wovenmaterial. In various embodiments, the cover 14 can be treated with anaqueous solution to reduce frictional drag and to enhance the ease ofinsertion into and withdrawal from a woman's vagina. In variousembodiments, the cover 14 can be constructed of a non-woven materialsuch as a 33 gsm non-woven Fiberweb®, Catalog No. 097YLJO09P. In variousembodiments, the cover 14 can be constructed of a non-woven material,such as, for example, constructed of about 50% polypropylene and about50% polyethylene. In various embodiments, the cover 14 can beconstructed of nylon. In various embodiments, the cover 14 and theremoval element 16 can be constructed of the same unitary piece ofmaterial and/or at the same time and/or in the same process. In variousembodiments, the cover 14 and the removal element 16 can be constructedof separate pieces of material. In various embodiments, the cover 14 canbe constructed of a non-absorbent material. In various embodiments, thecover 14 can be flexible and/or stretchable. In various embodiments, thecover 14 can be formed from a heat-shrinkable material. In variousembodiments, the cover 14 can be formed from a material which can beextensible and/or elastic. In various embodiments, elements of the cover14 can be bonded, stitched, sutured, and/or welded together. In variousembodiments, the bonds, stitches, sutures, and/or welds can be locatedinside the cover 14 opposite the vaginal wall. In various embodiments,the cover 14 and/or the core 12 can be adapted to allow the free flow ofvaginal discharge.

In various embodiments, the removal element 16 can be constructed of acotton material but can be constructed of other materials. In variousembodiments, the removal element 16 can be constructed of materialswhich can allow for absorbing fluids or can be constructed of materialswhich do not allow for absorbing fluids. In various embodiments, theremoval element 16 can be a thread or ribbon made from 100% cottonfibers. In various embodiments, the removal element 16 can beconstructed of non-absorbent polyurethane, optionally with a coating ofsilicone film which can provide a smooth surface to the removal element16. In various embodiments, the removal element 16 can be a siliconecoated, braided polyester, an example of which is manufactured byAshaway.

In various embodiments, the removal element 16 of the vaginal insert 10can be from about 14 cm to about 16 cm in length, although the lengthcan be varied in different vaginal insert 10 configurations. In anembodiment, the removal element 16 can be secured to the cover 14 in aposition whereby a pulling force towards the vaginal introitus can besubstantially evenly distributed over the cover 14 as it collapses thesupporting arms 28 of the core 12 within the vagina. In an embodiment,this position can be in the center of the cover 14 in the supportingelement 20 region, such as illustrated in FIG. 1.

In various embodiments, the cover 14 can reduce friction between thevaginal insert 10 and the vaginal wall. Pulling the removal element 16can cause tensioning of the cover 14. Tensioning of the cover 14 canresult in the straightening of the vaginal walls which can therebyreduce the tent-like effect described above and relieve tension appliedto the vaginal insert 10, allowing for an easy and smooth removal of thevaginal insert 10 from the vagina. Furthermore, pulling on the removalelement 16 can cause the collapse of supporting arms 28 at leastslightly towards the longitudinal axis 24 as a result of the forceapplied to them by cover 14, thereby reducing the radial diameter of thecore 12 and allowing for an easy and smooth removal of the vaginalinsert 10 from the vagina.

Besides being used as an aide in removal of the vaginal insert 10, anadditional use of the cover 14 can be to act as a sling stretchedbetween supporting arms 28, which can supply sub-urethral tension-freesupport to the urethra.

Referring to FIGS. 10-12, perspective views of an applicator 40 whichcan be utilized to deploy a vaginal insert 10 for treating urinaryincontinence are illustrated. In an embodiment, the applicator 40 cancomprise a housing 42 and a plunger 44. The housing 42 can be adaptedfor receipt and/or storage of the vaginal insert 10. In variousexemplary embodiments, plunger 44 can be used to expel the vaginalinsert 10 from the housing 42 during vaginal insert 10 deployment into avagina. FIG. 11 is a cross-section of the applicator of FIG. 10 alongline A-A which can show the configuration of applicator 40 more clearly,including the interface between housing 42 and plunger 44. In variousembodiments, housing 42 can be provided with an outlet 46. In variousembodiments, outlet 46 can be provided with a plurality of flexibleflaps (“petals”) which can be pushed open when vaginal insert 10 isexpelled from applicator 40. The outlet 46 is more clearly shown in FIG.12.

In the applicator 40, the vaginal insert 10 can be positioned such thatthe anchoring element 18 of the core 12 comes out of the applicator 40into the vagina first, followed by supporting element 20 of the core 12,which comes out at the end of the deployment process. In an embodiment,the vaginal insert 10 can be deployed to render support to the urethra.In an embodiment, the vaginal insert 10 can be deployed to rendersupport to the bladder neck.

In an embodiment, a user can receive the vaginal insert 10 in anindividual package 50 such as shown in FIG. 13. In an embodiment,different sizes and/or packages 50 with vaginal inserts 10 havingdifferent features can be color coded for ease of identification by auser of the vaginal insert 10. FIG. 13 is a side view of the componentparts of a product package 50 for a vaginal insert 10 for treatingurinary incontinence. Product package 50 can comprise an applicatorhousing 42, core 12, cover 14, removal element 16, applicator plunger44, and product wrapper 52. In an embodiment, product wrapper 52 can bewrapped around the applicator 40, which when packaged can include thevaginal insert 10 within the housing 42. Thus, product package 50 in itsassembled form can be more or less cylindrical or shaped like a wrappedtampon.

In an embodiment, insertion of the vaginal insert 10 into the vagina canbe similar to insertion of a tampon. The user can use one hand to spreadthe labia, direct the anterior part of the applicator 40 into thevagina, and compress the plunger 44 with the other hand, therebydeploying the vaginal insert 10 from the applicator 40 into the vagina.In an embodiment, there is no need for a specific orientation of thevaginal insert 10 because of the generally symmetrical design of thecore 12 about the longitudinal axis 24 of the core 12. The insertion ofthe vaginal insert 10 can be performed at any orientation and/oranywhere in the 360° around the longitudinal axis 24 of the core 12 inthe applicator 40.

In various embodiments, even though the core 12 can be designedsymmetrically, because each of the arms, 26 and 28, can flexindependently of the other arms, 26 and 28, when in situ and each vaginavaries in shape slightly, the vaginal insert 10 may not actually be insymmetrical form when in use (see FIG. 8). Referring to FIG. 8, a planview showing a possible relationship of the supporting arms 28 to thelongitudinal axis 24 of the core 12 when the vaginal insert 10 is insitu is illustrated. It is noted that not every vagina has the samecontours and internal structure, even though some generalizations can bemade about vaginal anatomical features. To that end, the core 12 can bedesigned to be adaptable to the varying vaginal features it may comeacross, depending on the user of the vaginal insert 10. For example,each of the supporting arms 28 of the core 12 can be capable offunctioning independently. This can enable maximal flexibility, maximaladjustment to any vaginal shape (cross section) and/or vaginaldimensions. Thus, it may happen that in a given cross section, thesupporting arms 28 of the core 12 will not be symmetrically spreadaround the longitudinal axis 24 of the core 12, such as shown in FIG. 8.

The core 12 can be manufactured and/or commercially available in aplurality of sizes, with each size exhibiting different performancecharacteristics, operational dimensions, weight and the like. In variousembodiments, differently sized cores 12 can be made of the samematerial. In various embodiments, differently sized cores 12 can usedifferent materials and/or different material ratios. FIGS. 14A-14C area series of charts illustrating exemplary core 12 sizes. As can be seenin the charts of FIGS. 14A-14C, core 12 can be produced in at least foursizes for optimal adjustment to various vaginal dimensions and/or inaccordance with the severity of urinary incontinence. The various sizescan differ in the diameter of the supporting arm's 28 spread and as aresult, can differ in the overall length when deployed (i.e., thesupporting arms 28 are spread). In various embodiments, the anchoringarms 26 can have identical deployed dimensions and/or performancecharacteristics in all of the sizes.

In various embodiments, core 12 can be constructed of liquid silicone(LSR) by injection molding. It is possible to use other materials, forexample TPE, non-liquid silicone, and others for a core 12 of the samesize. In an embodiment, materials exhibiting various degrees of Shore Ahardness can be used to produce softer or more rigid cores 12.

It should be understood that the various size combinations can be madeby varying the size and/or Shore A hardness. For example, sizes 1 and 2,could be made with a Shore A hardness of 70 while sizes 3 and 4 can havea Shore A hardness of 40. In various embodiments, all of the core 12sizes can exhibit the same Shore A hardness. In various embodiments,each individual size can be made in multiple versions, each exhibiting adifferent Shore A hardness. In sum, various combinations andpermutations of features, sizes, performance characteristics and/orconstruction materials can be employed to apply desired sub-urethralsupporting force at certain working angles.

In various embodiments, the radiating supporting arms 28 of core 12 cancreate an overall core 12 diameter from about 34 or 41 mm to about 50,51 or 52 mm at the widest supporting element 20 cross section within thevaginal cavity. In various embodiments, the diameter can be larger orsmaller depending on the individual needs of the user.

FIG. 15 is a core 12 performance graph correlating expansive forceexerted by supporting arms 28 (y-axis) to amount of medial deflection(x-axis) and hardness (line hatchings) for each of the four basic sizesshown in FIGS. 14A-14C whereby medial deflection is the distance in mmtowards the longitudinal axis 24 of the core 12 from the naturalexpanded state of the supporting arm 28.

The expansive force exerted by the supporting arms 28 is generallydetermined by the hardness grade and/or the medial flexion degree(medial deflection) of each of the supporting arms 28 relative to thelongitudinal axis 24. If a specific material is used in construction ofthe core 12, such as, for example, liquid silicone, these forces can bemeasured for any given diameter of the supporting arms 28 of the core12, knowing the performance characteristics of the specific materialbeing used. Using this data in a graph where the x-axis represents thecore 12 diameter and the y-axis represents the force, the forces exertedby the supporting arms 28 for a given core 12 size and its materialhardness grade can be demonstrated. The slope represents the ratiobetween the force (grams) and the amount of medial deflection (mm).

In designing and/or selecting a core 12 for use, certain performanceconsiderations can be taken into account. It should be noted that core12 support is “activated” by the supporting arms 28 being compressed(i.e., deflected towards the longitudinal axis 24 of the core 12, or“medial deflection”) at least slightly by the vaginal wall. In general,the stronger the compressive forces on the supporting arms 28, thestronger the support force that is exerted back onto the vaginalwall/sub-urethra by the supporting arms 28. For example, supporting arms28 must be compressed a certain minimal amount in order to providecounterforce sufficient for the supporting arms 28 to render support.That is, if a vaginal insert 10 is inserted into a vagina and the core12 is too small or the angle of radial expansion is too small, then notenough force will be applied to the supporting arms 28 from the vaginalwall to cause the supporting arms 28 to counter with the force requiredto render appropriate and effective support. Failure to achieve thisminimal value of compression in an at-rest state, shown as a horizontalminimal applied force line 60 in FIG. 15 at approximately 10 g of force,on the supporting arms 28 during a stressful event will reduce vaginalinsert 10 efficacy. It should be noted that in some embodiments, theminimal applied force line 60 at 10 g is approximate and can vary ±3grams.

Similarly, there exists a maximum force exerted by the core 12 on thevaginal walls beyond which the user would experience discomfort whilethe vaginal insert 10 is in the vagina at-rest and/or while removing thevaginal insert 10. In an embodiment, therefore, the core 12 can bedesigned and/or selected for use not to exceed this maximal force. Thismaximal force is represented in FIG. 15 as the bold horizontal line 62at approximately 50 g of force. In an embodiment, 50 grams isapproximate and can vary ±5 grams. For example, if the radial expansionof the supporting arms 28 is too great, it will generate excessive forceon the vaginal wall and the user may experience discomfort, which is tobe avoided.

The graph of FIG. 15 can be used, in various embodiments, to determinethe use potential for a specific core 12 configuration for a specificvaginal size. For example, D1 on the graph represents a vagina with adiameter of 33 mm. Referring to FIG. 15, it can be seen that size 1cores 12 with Shore A hardnesses of S40 and S50 are not indicated foruse with this user because they will not provide sufficiently effectivesupport in an at-rest state. However, a number of other core 12 sizesand Shore A hardnesses are considered acceptable:

-   -   Size 1 with Shore A hardness of 70 device (supplying force of        about 21 grams)    -   Size 2 with Shore A hardness of 50 device (supplying force of        about 25 grams)    -   Size 2 with Shore A hardness of 40 device (supplying force of        about 20 grams)    -   Size 3 with Shore A hardness of 50 device (supplying force of        about 38 grams)    -   Size 3 with Shore A hardness of 40 device (supplying force of        about 28 grams)    -   Size 4 with Shore A hardness of 50 device (supplying force of        about 48 grams)    -   Size 4 with Shore A hardness of 40 device (supplying force of        about 35 grams)

As another example, D2 on the graph represents a vagina with a diameterof 42.5 mm. Because of the size of this user's vagina, fewer choices maybe available for receiving ideally efficacious vaginal support. In thisexample, likely choices would include:

-   -   Size 3 with Shore A hardness of 70 device (supplying force of        about 22 grams)    -   Size 4 with Shore A hardness of 70 device (supplying force of        about 45 grams)    -   Size 4 with Shore A hardness of 50 device (supplying force of        about 22 grams)    -   Size 4 with Shore A hardness of 40 device (supplying force of        about 18 grams)

It is noted that a size 4 core 12 made of a low Shore A hardnessmaterial, for example 40, can be used for a wide variety of vaginaldiameters (approximately 30 mm to 45 mm), in an exemplary embodiment.

Above the maximum force line 62, the graph of FIG. 15 shows forceexertion levels of the various core 12 sizes at different levels ofmedial deflection all the way down to about 12 mm in total core 12diameter. In an embodiment, each arm is approximately 6 mm in width,therefore the minimum diameter distance possible is when two opposingarms have come into contact or 12 mm (6 mm+6 mm) Specific numbers forselected core 12 sizes are shown in and described in more detail belowwith respect to FIG. 16.

FIG. 16 is a table showing specific performance levels for exemplarybasic core 12 sizes and Shore A hardnesses depicted in FIG. 15. Theminimal diameter column lists the diameter (in mm) at which two opposingarms 28 come into contact thereby substantially prohibiting any furthermedial deflection by the arms 28. In an embodiment, maximal force isexerted when the cores 12 are compressed the most, or at the minimaldiameter. The max force column lists the maximum amount of force exertedby each listed core 12 size and Shore A hardness at the 12 mm diameterlevel.

It is noted that some of the information shown in FIG. 16 is alsoincluded in the tables of FIGS. 14A-14C. Where the information is notentirely in conformance, it should be understood that the broadest rangeof values is to be attributed to the embodiments described herein. Forexample, a range of values may be taken where the low end of the rangeis from one table and the high end of the range is from another table.It should also be noted that values given are by way of example only,and that core 12 performance characteristics can vary depending onmaterials used for construction and/or core 12 size and/or Shore Ahardness.

In various embodiments, many of the possible sizes of cores 12 can besuitable for a particular user and sufficient support can be providedwithout surpassing the discomfort threshold. This can be particularlytrue with cores 12 of low Shore A hardness and moderate slope. Forexample, a core 12 of size 3 (support diameter—45 mm) made of softsilicone with a Shore A hardness of 40 may be suitable for a broad rangeof vaginal diameters: exerting a force of 12 grams over a diameter of 40mm, 21 grams over a diameter of 35 mm, and 31 grams over a diameter of30 mm. In other words, in some embodiments, a single core 12 size canprovide support to numerous vaginal dimensions. In an embodiment, a core12 can be adapted to be usable by a variety of users, for example bydesigning a core 12 with a low or moderate slope.

It is possible that only one size of core 12 will be suitable for awoman with a certain vaginal diameter, especially if her vaginaldimensions are larger than the average. In some embodiments, only sizes3 or 4 would be suitable, while the smaller sizes would not exert theminimal support force required. It should be noted that characteristicssuch as the force applied, the size of the vaginal insert 10 and/oroverall comfort of the vaginal insert 10 chosen is highly dependent oneach individual user and may also depend on the pathological responsecaused by the vaginal insert 10 for each individual user.

In an exemplary embodiment, reducing the distance between the supportingtip 32 of a supporting arm 28 and the longitudinal axis 24 of the core12 would increase the force exerted by the core 12 at the supporting tip32. The operative significance of this can be that a relatively largevaginal insert 10 inserted into the vagina would exert a higher force onthe vaginal walls as compared to a smaller vaginal insert 10 insertedinto the same vagina. Using this same rationale, if external forcesexerted on the vaginal insert 10 reduce the internal distance betweenits supporting arms 28 and the longitudinal axis 24 (e.g. duringcoughing, jumping, sneezing, etc.), a greater counteracting force wouldbe exerted by the supporting arms 28 on the vaginal walls, thusenhancing the urethral support and the efficiency of urinary leakprevention. Therefore, in an exemplary embodiment, a vaginal insert 10can be designed with this activity-generated counter tension in mind.

As described herein, a core 12 of a vaginal insert 10 can bemanufactured in a variety of sizes, with each size different fromanother size, wherein the difference can be one of exhibiting adifferent performance characteristic, material hardness, operationaldimension, weight, overall diameter of the supporting element 20 of thecore 12 when the supporting arms 28 are radially expanded, and/or theradial spread angle at which the supporting arms 28 protrude outwardlyrelative to the longitudinal axis 24 of the core 12. The variety ofcores 12 can, therefore, result in a variety of vaginal inserts 10. Amanufacturer of such a variety of vaginal inserts 10 may find itbeneficial (such as, related to cost and simplifying the manufacturingprocess) to place the resultant variety of vaginal inserts 10 into thesame size of applicator 40 (such as illustrated in FIGS. 10-12). Inother words, in various embodiments, one size of applicator 40 can beused to house any of the variety of vaginal inserts 10 wherein a vaginalinsert 10 can have a core 12 which can differ from the core 12 of asecond vaginal insert 10.

As a non-limiting example, the following are three examples of differentsizes of cores 12 contemplated by the current disclosure which can beutilized in a vaginal insert 10 contemplated by the current disclosure:

-   -   A first core 12 can have an anchoring element 18, a supporting        element 20, and a node 22 located between the anchoring element        18 and the supporting element 20. In the radially expanded        configuration, the anchoring element 18 of the first core 12 can        have a diameter of about 32 mm±1 mm, the supporting element 20        can have a diameter of about 41 mm±1 mm, and the longitudinal        length of the first core 12 can be about 42 mm±1 mm. The first        core 12 can be manufactured from a soft silicone polymer and can        have a Shore A hardness of 50.    -   A second core 12 can have an anchoring element 18, a supporting        element 20, and a node 22 located between the anchoring element        18 and the supporting element 20. In the radially expanded        configuration, the anchoring element 18 of the second core 12        can have a diameter of about 32 mm±1 mm, the supporting element        20 can have a diameter of about 50 mm±1 mm, and the longitudinal        length of the second core 12 can be about 37 mm±1 mm. The second        core 12 can be manufactured from a soft silicone polymer and can        have a Shore A hardness of 50.    -   A third core 12 can have an anchoring element 18, a supporting        element 20, and a node 22 located between the anchoring element        18 and the supporting element 20. In the radially expanded        configuration, the anchoring element 18 of the third core 12 can        have a diameter of about 32 mm±1 mm, the supporting element 20        can have a diameter of about 50 mm±1 mm, and the longitudinal        length of the third core 12 can be about 37 mm±1 mm. The third        core 12 can be manufactured from a soft silicone polymer and can        have a Shore A hardness of 70.

In the example just described, the first core 12 and the second core 12can exhibit the same Shore A hardness of 50 but the third core 12 canexhibit a Shore A hardness which is different from the Shore A hardnessof the first core 12 and second core 12. While the first core 12 and thesecond core 12 can have the same Shore A hardness, the supportingelement 20 of each of the first core 12 and the second core 12 can havedifferent diameter dimensions when in the radially expandedconfiguration. In the example just described, the supporting element 20of each of the second core 12 and the third core 12 can have the samediameter dimension when in the radially expanded configuration.

Each of the first core 12, second core 12, and third core 12 can beutilized in the manufacture of a vaginal insert 10 as contemplated bythis disclosure. As mentioned above, in such a non-limiting example, amanufacturer of such a variety of cores 12, and the resultant variety ofvaginal inserts 10, may find it beneficial (such as, related to cost andsimplifying the manufacturing process) to insert each of the cores 12just described, and the resultant variety of vaginal inserts 10, intothe same size of applicator 40 (such as illustrated in FIGS. 10-12).

To house the core 12, and resultant vaginal insert 10, in an applicator40, the core 12 is converted from a radially expanded configuration toan inwardly compressed configuration (such as illustrated in FIG. 7).The inwardly compressed core 12, and resultant vaginal insert 10, canthen be loaded into the applicator 40 for storage until such time asneeded by a woman. A shortcoming which can be associated with simplyplacing an inwardly compressed core 12, and resultant vaginal insert 10,into an applicator 40 can be that, as the core 12 of the vaginal insert10 is under compression, the core 12, and therefore, the vaginal insert10 can have a tendency to migrate towards the outlet 46 of theapplicator 40 such as, for example, during shipping and handling. Themigration of the vaginal insert 10 towards the outlet 46 of theapplicator 40 can result in premature self-expulsion of the vaginalinsert 10 from the applicator 40 or can result in at least partialopening of the petals of the outlet 46 which can result in anuncomfortable insertion experience for the woman attempting to utilizethe vaginal insert 10.

The migration of the vaginal insert 10, the at least partial opening ofthe petals of the outlet 46 of an applicator 40, and/or theself-expulsion of the vaginal insert 10 can be impeded in a variety ofways, such as, but not limited to, stiffening the petals of the outlet46, narrowing an inside diameter tapering of the housing 42 of theapplicator 40 near the outlet 46 of the applicator 40, increasing thesurface friction on an inner surface of the housing 42 of the applicator40 via texturing or other means, altering the topography of the innersurface of the housing 42 of the applicator 40, and/or holding thevaginal insert 10 in place with a physically attached element such as,for example, a string or other means. Packaging elements external to theapplicator 40 can also assist in reducing and/or eliminating thedrawbacks described. Such packaging elements can include, but are notlimited to, blister packaging, using an injection molded cap, a nonwovensleeve and/or shrinkwrap or other means over the outlet 46 of theapplicator 40.

In various embodiments, the core 12 of the vaginal insert 10 can bemodified to enable the core 12 to provide an outward force inside thehousing 42 of the applicator 40 to retain the vaginal insert 10 insidethe housing 42 of the applicator 40 until ready to expel. In variousembodiments, any modification made to the core 12 of the vaginal insert10 can coordinate with the characteristics and/or design of the housing42 of the applicator 40. Such coordination of the modifications made tothe core 12 of the vaginal insert 10 with the characteristics and/ordesign of the housing 42 of the application 40 can provide for improvedinteraction between the vaginal insert 10 and the applicator 40 and canreduce and/or eliminate the migration of the vaginal insert 10 throughthe applicator 40 towards the outlet 46 of the applicator. In variousembodiments, the expulsion force required to retain the vaginal insert10 within the housing 42 of the applicator 40 should be high enough tomaintain the vaginal insert 10 enclosed behind the petals of the outlet46 of the applicator 40 during normal shipping and handling and alsoallow for ease of expulsion of the vaginal insert 10 from the applicator40 when needed by a woman. In various embodiments, the expulsion forcecan range from about 150 to about 4,500 grams force.

In various embodiments, the core 12 of the vaginal insert 10 can beprovided with a migration reduction feature. In various embodiments, thecore 12 of the vaginal insert 10 can be provided with a plurality ofmigration reduction features. In various embodiments, the core 12 of thevaginal insert 10 can be provided with at least 1, 2, 3, 4, 5, 6, 7, 8,9, 10, 11, 12, 13, 14, 15, or 16 migration reduction features. Invarious embodiments, the migration reduction feature can operate byincreasing the friction between the vaginal insert 10 and the innersurface of the housing 42 of the applicator 40. In various embodiments,the migration reduction feature can be located in any location of thecore 12 as deemed suitable, such as, for example, an applicator facingsurface of the core 12, a non-applicator facing surface of the core 12,or a combination thereof.

A migration reduction feature located on an applicator facing surface ofthe core 12, such as, for example, an applicator facing surface of theanchoring arms 26 and/or supporting arms 28 of the core 12, caninteract, directly or indirectly, with the inner surface of the housing42 of an applicator 40, such as, for example, a surface texture or analtered topography of the inner surface of the housing 42, to assist inpreventing or minimizing the migration of the vaginal insert 10 throughthe applicator 40. In various embodiments, the migration reductionfeatures can directly interact with the inner surface of the housing 42of the applicator 40 in such embodiments wherein the migration reductionfeature can directly contact the inner surface of the housing 42 of theapplicator 40 (e.g., the vaginal insert 10 does not have a cover 14). Invarious embodiments, the migration reduction feature can interactindirectly with the inner surface of the housing 42 of the applicator 40in such embodiments wherein the migration reduction feature cannotdirectly contact the inner surface of the housing 42 of the applicator40 (e.g., the vaginal insert 10 has a cover 14).

A migration reduction feature positioned on a non-applicator facingsurface of the core 12, such as, for example, a non-applicator facingsurface of the anchoring arms 26 and/or supporting arms 28 of the core12, can interact with another migration reduction feature alsopositioned on a non-applicator facing surface of the core 12, such as,for example, a non-applicator facing surface of the anchoring arms 26and/or supporting arms 28. The interaction, such as, for example, apushing of one of the migration reduction features against and away fromanother of the migration reduction features, can force the arms, such asanchoring arms 26 and/or supporting arms 28, in an outward directionrelative to the longitudinal axis 24 of the core 12. The pushing of theanchoring arms 26 and/or supporting arms 28 in an outward direction canresult in the application of a force against the inner surface of thehousing 42 of the applicator 40 which can prevent or minimize themigration of the vaginal insert 10 through the applicator 40.

In various embodiments, the size dimensions of the migration reductionfeature can be designed as deemed suitable to promote interactionbetween the core 12 of the vaginal insert 10 and the inner surface ofthe housing 42 of the applicator 40. In various embodiments, the sizedimensions of a migration reduction feature positioned on an applicatorfacing surface of the core 12 can be sized as deemed suitable to promoteinteraction, direct or indirect, between the migration reduction featureand the inner surface of the housing 42 of the applicator 40. In variousembodiments, the size dimensions of a migration reduction featurepositioned on a non-applicator facing surface of the core 12 can besized as deemed suitable to promote interaction between at least twomigration reduction features positioned on a non-applicator facingsurface of the core 12 within the same element, anchoring 18 orsupporting 20, of the core 12.

In various embodiments, the number of, positioning of, and/or size ofthe migration reduction feature(s) on the core 12 can be designed asdeemed suitable to prevent or minimize migration of the vaginal insert10 within the housing 42 of the applicator 40. While such designs of themigration reduction feature can be made to prevent or minimize migrationof the vaginal insert 10 through the applicator 40, such designs shouldnot result in an expulsion force which is too high, thereby, creatingdifficulty for the user to expel the vaginal insert 10 from theapplicator 40 when needed for use. As described herein, the core 12 ofthe vaginal insert 10 can be made in a variety of size and/or canexhibit a variety of performance characteristics such as Shore Ahardness. In various embodiments, the expulsion force for each core 12and resultant vaginal insert 10, regardless of size and/or exhibitedperformance characteristic, would be substantially similar.

In various embodiments, a migration reduction feature can be located onan anchoring arm 26 or a supporting arm 28 of a core 12. In variousembodiments, such as, for example, in various embodiments wherein morethan one migration reduction feature can be present, the plurality ofmigration reduction features can all be positioned within the anchoringelement 18, can all be positioned within the supporting element 20, orcombinations thereof, of a core 12. In various embodiments, a migrationreduction feature can be located on an applicator 40 facing surface or anon-applicator facing surface of a core 12. In various embodiments, suchas, for example, in various embodiments wherein more than one migrationreduction feature can be present, the plurality of migration reductionfeatures can all be positioned on an applicator facing surface, can allbe positioned on a non-applicator facing surface, or combinationsthereof, of a core 12.

In various embodiments, a migration reduction feature can be positionedon an anchoring arm 26 of a core 12. In various embodiments, a migrationreduction feature can be located at any position on the anchoring arm26, such as, for example, closer to the node 22, closer to the anchoringtips 30, or closer to the midpoint of the anchoring arm 26. In variousembodiments, a migration reduction feature can be located atsubstantially an inflection point of the anchoring arm 26 when the core12 of the vaginal insert 10 is compressed within the housing 42 of theapplicator 40. In various embodiments, the size, type, location,material construction, etc of the migration reduction feature can bevaried and adjusted dependent upon the size and composition (sizedimensions and/or exhibited performance characteristic) of the core 12of a vaginal insert 10. For example, a core 12 may be designed to have aparticular size and exhibit a particular Shore A hardness and the type,size, location and material construction of a migration reductionfeature associated with the core 12 can be adjusted based upon theselected size and Shore A hardness of the core 12 in order to prevent orminimize the migration of the vaginal insert 10 in an applicator 40.

As described above, in various embodiments, the migration reductionfeature can be positioned on an applicator facing surface of ananchoring arm 26 of the core 12. In such various embodiments, the size,type, material construction, etc. of the migration reduction feature canbe varied and adjusted dependent upon a modification made to the innersurface of the housing 42 of the applicator 40. In such variousembodiments, the type, size, location and material construction of themigration reduction feature can be sized and adjusted to promoteinteraction between the migration reduction feature and the innersurface of the housing 42 of the applicator 40 to prevent or minimizemigration of the vaginal insert 10 within the housing 42 of theapplicator 40.

As described above, in various embodiments, the migration reductionfeature can be positioned on a non-applicator facing surface of the core12. In such various embodiments, the size, type, material construction,etc., of the migration reduction feature can be sized and adjusted suchthat the migration reduction feature can interact with another migrationreduction feature positioned on a non-applicator facing surface of asecond anchoring arm 26 of the anchoring element 18 which can result inan application of a force against the inner surface of the housing 42 ofan applicator 40 to prevent or minimize migration of the vaginal insert10 within the housing 42 of the applicator 40.

In various embodiments, a migration reduction feature can be positionedon a supporting arm 28 of a core 12. In various embodiments, a migrationreduction feature can be located at any position on the supporting arm28, such as closer to the node 22, closer to the supporting tips 32, orcloser to the midpoint of the supporting arm 28. In various embodiments,a migration reduction feature can be located at substantially aninflection point of the supporting arm 28 when the core 12 of thevaginal insert 10 is compressed within the housing 42 of the applicator40. In various embodiments, the size, type, location, materialconstruction, etc., of the migration reduction feature can be varied andadjusted dependent upon the size and composition (size dimensions and/orexhibited performance characteristic) of the core 12 of a vaginal insert10. For example, a core 12 may be designed to have a particular size andexhibit a particular Shore A hardness and the type, size, location, andmaterial construction of a migration reduction feature associated withthe core 12 can be adjusted based upon the selected size and Shore Ahardness of the core 12 in order to prevent or minimize the migration ofthe vaginal insert 10 in an applicator 40.

As described above, in various embodiments, the migration reductionfeature can be positioned on an applicator facing surface of asupporting arm 28 of the core 12. In such various embodiments, the size,type, material construction, etc. of the migration reduction feature canbe varied and adjusted dependent upon a modification made to the innersurface of the housing 42 of the applicator 40. In various embodiments,the type, size, location and material construction of the migrationreduction feature can be sized and adjusted to promote interactionbetween the migration reduction feature and the inner surface of thehousing 42 of the applicator 40 to prevent or minimize migration of thevaginal insert 10 within the housing 42 of the applicator 40.

As described above, in various embodiments, the migration reductionfeature can be positioned on a non-applicator facing surface of the core12. In such various embodiments, the size, type, material construction,etc. of the migration reduction feature can be sized and adjusted suchthat the migration reduction feature can interact with another migrationreduction feature positioned on a non-applicator facing surface of asecond supporting arm 28 of the supporting element 20 which can resultin an application of a force against the inner surface of the housing 42of an applicator 40 to prevent or minimize migration of the vaginalinsert 10 within the housing 42 of the applicator 40.

In various embodiments, a vaginal insert 10 can have a core 12 which canhave at least one migration reduction feature located within theanchoring element 18. In various such embodiments, the at least onemigration reduction feature can be positioned on an applicator facingsurface of at least one anchoring arm 26. In various such embodiments,the at least one migration reduction feature can be positioned on anon-applicator facing surface of at least one anchoring arm 26.

In various embodiments, a vaginal insert 10 can have a core 12 which canhave at least two migration reduction features located within theanchoring element 18. In various such embodiments, one of the at leasttwo migration reduction features can be positioned on an applicatorfacing surface of a first anchoring arm 26 and a second of the at leasttwo migration reduction features can be positioned on an applicatorfacing surface of a second anchoring arm 26. In various suchembodiments, one of the at least two migration reduction features can bepositioned on a non-applicator facing surface of a first anchoring arm26 and a second of the at least two migration reduction features can bepositioned on a non-applicator facing surface of a second anchoring arm26. In various such embodiments, one of the at least two migrationreduction features can be positioned on an applicator facing surface ofan anchoring arm 26 and a second of the at least two migration reductionfeatures can be positioned on a non-applicator facing surface of ananchoring arm 26 (either the same anchoring arm 26 upon which the firstmigration reduction feature is positioned or a different anchoring arm26).

In various embodiments, a vaginal insert 10 can have a core 12 which canhave at least one migration reduction feature located within thesupporting element 20. In various such embodiments, the at least onemigration reduction feature can be positioned on an applicator facingsurface of at least one supporting arm 28. In various such embodiments,the at least one migration reduction feature can be positioned on anon-applicator facing surface of at least one supporting arm 28.

In various embodiments, a vaginal insert 10 can have a core 12 which canhave at least two migration reduction features located within thesupporting element 20. In various such embodiments, one of the at leasttwo migration reduction features can be positioned on an applicatorfacing surface of a first supporting arm 28 and a second of the at leasttwo migration reduction features can be positioned on an applicatorfacing surface of a second supporting arm 28. In various suchembodiments, one of the at least two migration reduction features can bepositioned on a non-applicator facing surface of a first supporting arm28 and a second of the at least two migration reduction features can bepositioned on a non-applicator facing surface of a second supporting arm28. In various such embodiments, one of the at least two migrationreduction features can be positioned on an applicator facing surface ofa supporting arm 28 and a second of the at least two migration reductionfeatures can be positioned on a non-applicator facing surface of asupporting arm 28 (either the same supporting arm 28 upon which thefirst migration reduction feature is positioned or a differentsupporting arm 28).

In various embodiments, a vaginal insert 10 can have a core 12 which canhave at least one migration reduction feature located within theanchoring element 18 and at least one migration reduction featurelocated within the supporting element 20. In various such embodiments,the at least one migration reduction feature located in the anchoringelement 18 and the at least one migration reduction feature located inthe supporting element 20 can each be positioned on an applicator facingsurface of the core 12. In various such embodiments, the at least onemigration reduction feature located in the anchoring element 18 and theat least one migration reduction feature located in the supportingelement 20 can each be positioned on a non-applicator facing surface ofthe core 12. In various such embodiments, one of the at least onemigration reduction feature located in the anchoring element 18 and theat least one migration reduction element located in the supportingelement 20 can be positioned on an applicator facing surface of the core12 and the other of the at least one migration reduction feature locatedin the anchoring element 18 and the at least one migration reductionelement located in the supporting element 20 can be positioned on anon-applicator facing surface of the core 12.

In various embodiments, a migration reduction feature can be integralwith the core 12 such as, for example, by being molded with the core 12at the time of manufacture of the core 12. In various embodiments, amigration reduction feature be formed separately from the core 12 andcan be bonded with the core 12. The term “bonded” refers herein to thejoining, adhering, connecting, attaching, or the like, of two elements.Two elements will be considered bonded together when they are joined,adhered, connected, attached, or the like, directly to one another orindirectly to one another, such as when each is directly bonded tointermediate elements. The bonding can occur via adhesive, pressurebonding, thermal bonding, ultrasonic bonding, and/or welding, or anyother means deemed suitable.

In various embodiments, a migration reduction feature can be located onan applicator facing surface of the core 12. Referring to FIGS. 17A-17D,an illustration of a non-limiting example of an embodiment of at leastone migration reduction feature 70 located on an applicator facingsurface 80 of the core 12 can be viewed. In various embodiments, atleast one migration reduction feature 70 can be located on an applicatorfacing surface 80 of at least one supporting arm 28, at least oneanchoring arm 26, or combination thereof, of a core 12. In the exemplaryembodiment as illustrated in FIGS. 17A-17D, a migration reductionfeature 70 can be located on an applicator facing surface 80 of each ofthe supporting arms 28 of the core 12. FIG. 17A provides a perspectiveview of an illustration of a non-limiting example of an embodiment of amigration reduction feature 70 located on an applicator facing surface80 of each of the supporting arms 28 of a core 12. FIG. 17B provides anillustration of a side view of the core 12 of FIG. 17A. FIG. 17Cprovides an illustration of a cross-sectional view of the core 12 ofFIG. 17B taken along line A-A. In various embodiments, such as when themigration reduction feature 70 can be located on the applicator facingsurface 80 of the supporting arms 28, the migration reduction feature 70can be placed at any distance 72 from the supporting tips 32 as deemedsuitable to interact with the inner surface of the housing 42 of anapplicator 40 to prevent or minimize migration of the vaginal insert 10within the housing 42 of an applicator 40. In various embodiments, thedistance 72 from the supporting tip 32 to the trailing end 76(illustrated in FIG. 17D) of the migration reduction feature 70 can befrom about 14, 15 or 16 mm to about 17, 18, 19 or 20 mm.

FIG. 17D provides a close-up view of the Area B of the core 12 of FIG.17C and provides an illustration of a non-limiting example of amigration reduction feature 70. As illustrated in FIG. 17D, themigration reduction feature 70 can extend outwardly from an applicatorfacing surface 80 of a supporting arm 28. The migration reductionfeature 70 can have a leading end 74 and a trailing end 76. In theembodiment illustrated, the leading end 74 can be the portion of themigration reduction feature 70 which can be closest to the node 22 ofthe core 12 and which can initiate the outward extension of themigration reduction feature 70 from the applicator facing surface 80 ofthe core 12. In the embodiment illustrated, the trailing end 76 can bethe portion of the migration reduction feature 70 which can be closestto the supporting tips 32 of the core 12 and which can terminate theoutward extension of the migration reduction feature 70 from theapplicator facing surface 80 of the core 12.

The migration reduction feature 70 can extend outwardly from theapplicator facing surface 80 of the core 12 any height 82 as deemedsuitable to interact with the inner surface of the housing 42 of theapplicator 40 to prevent or minimize migration of the vaginal insert 10.In various embodiments, the height 82 of the migration reduction feature70, as measured from the applicator facing surface 80 of the core 12 tothe outermost extension of the migration reduction feature 70, can befrom about 0.20, 0.25, 0.30, 0.40, 0.50, 0.60, 0.70, 0.75, or 0.80 mm toabout 0.90, 1.00, 1.10, 1.20, 1.30, 1.40, 1.50 or 1.60 mm.

In various embodiments, the migration reduction feature 70 can containat least one divot 78 between the leading end 74 and the trailing end 76of the migration reduction feature 70. The divot 78 can create areduction in the height 82 of the migration reduction feature 70 (at thelocation of the divot 78) and, thereby, provide the migration reductionfeature 70 with ridges, such as, for example, ridges 88 and 90. Invarious embodiments, the migration reduction feature 70 can have as manydivots 78 and ridges, such as ridges 88 and 90, as deemed suitable. Invarious embodiments, the migration reduction feature 70 can have nodivot 78 and, therefore, can be a single outward extension from theapplicator facing surface 80 of the core 12. In various embodiments, themigration reduction feature 70 can have at least 1, 2, 3 or 4 divots 78and, therefore, can have at least 2, 3, 4, or 5 ridges, such as ridges88 and 90, extending from the applicator facing surface 80 of the core12. In various embodiments in which at least two ridges are present inthe migration reduction feature 70, each ridge can outwardly extend fromthe applicator facing surface 80 of the core 12 the same height 82. Invarious embodiments in which at least two ridges are present in themigration reduction feature 70, a ridge can outwardly extend from theapplicator facing surface 80 of the core 12 a height 82 which can differfrom the height 82 of another ridge present in the migration reductionfeature 70. In various embodiments, the height 82 of a ridge of amigration reduction feature 70 can range from about 0.20, 0.25, 0.30,0.40, 0.50, 0.60, 0.70, 0.75, or 0.80 mm to about 0.90, 1.00, 1.10,1.20, 1.30, 1.40, 1.50, or 1.60 mm.

As illustrated in the non-limiting example of an embodiment of amigration reduction feature 70 illustrated in FIG. 17D, the migrationreduction feature 70 can have an overall length 84 from the leading end74 to the trailing end 76. The overall length 84 of the migrationreduction feature 70 can be any overall length 84 as deemed suitable andthe migration reduction feature 70 can contain as many divots 78 andridges, such as ridges 88 and 90, within the overall length 84 as deemedsuitable. In various embodiments, the overall length 84 of the migrationreduction feature 70 can be from about 2.0, 2.5, 3.0, 3.5, or 4.0 mm toabout 4.5, 5.0, 5.5, or 6.0 mm. In various embodiments in which themigration reduction feature contains a divot 78, the divot 78 can belocated at any location along the overall length 84 of the migrationreduction feature 70 as deemed suitable. For example, in an embodimentin which the migration reduction feature 70 has a single divot 78,thereby creating two ridges, such as ridges 88 and 90, the divot 78 canbe located halfway between the leading end 74 and the trailing end 76 orcan be located closer to either of the leading end 74 or the trailingend 76 as deemed suitable. In the non-limiting embodiment illustrated inFIG. 17D, the divot 78 can be located closer to the leading end 74 ofthe migration reduction feature 70. In the exemplary embodiment, as thedivot 78 can be located closer to the leading end 74 of the migrationreduction feature 70, the length 86 between the divot 78 and thetrailing end 76 can be more than half of the overall length 84 betweenthe leading end 74 and the trailing end 76 of the migration reductionfeature 70. As an example, if the overall length 84 between the leadingend 74 and the trailing end 76 of the migration reduction feature can beabout 3 mm, the length 86 between the divot 78 and the trailing end 76can be about 2 mm.

As a non-limiting example, in various embodiments, a core 12 can be madeaccording to the design illustrated in FIGS. 17A-17D and can have thefollowing configuration: The core 12 can be manufactured from a softsilicone polymer and can have a Shore A hardness of 70. The core 12 canhave an anchoring element 18, a supporting element 20, and a node 22located between the anchoring element 18 and the supporting element 20.In the radially expanded configuration, the anchoring element 18 of thecore 12 can have a diameter 92 of about 32 mm±1 mm, the supportingelement 20 can have a diameter 94 of about 50 mm±1 mm, and the length 96of the core 12 can be about 37 mm±2 mm. The core 12 can include amigration reduction feature 70 located on the applicator facing surface80 of each of the supporting arms 28 of the supporting element 20. Themigration reduction feature 70 can have a leading end 74 and a trailingend 76 and can have an overall length 84 of about 3 mm from the leadingend 74 to the trailing end 76. The distance 72 from the supporting tip32 to the trailing end 76 can be about 16 mm. The migration reductionfeature 70 can include a divot 78, thereby producing two ridges, 88 and90. The divot 78 can be positioned closer to the leading end 74 of themigration reduction feature 70 and the length 86 between the divot 78and the trailing end 76 can be more than half of the overall length 84of the migration reduction feature 70. In this example, the length fromthe divot 78 to the trailing end 76 can be about 2 mm. Each of theridges, 88 and 90, can extend from the applicator facing surface 80 ofthe core 12 to substantially the same height 82 and such height 82 ofeach ridge can be about 0.5 mm±0.050 mm.

In various embodiments, a migration reduction feature can be located ona non-applicator facing surface of the core 12. Referring to FIGS.18A-18E, an illustration of a non-limiting example of an embodiment ofat least one migration reduction feature 100 located on a non-applicatorfacing surface 102 of the core 12 can be viewed. In various embodiments,at least one migration reduction feature 100 can be located on anon-applicator facing surface 102 of at least one supporting arm 28, atleast one anchoring arm 26, or combination thereof, of a core 12. In theexemplary embodiments illustrated in FIGS. 18A-18E, a migrationreduction feature 100 can be located on a non-applicator facing surface102 of each supporting arm 28 of the core 12. FIG. 18A provides aperspective view of an illustration of a non-limiting example of anembodiment of a migration reduction feature 100 located on anon-applicator facing surface 102 of a core 12. FIG. 18B provides anillustration of a side view of the core 12 of FIG. 18A. FIG. 18Cprovides an illustration of a cross-sectional view of the core 12 ofFIG. 18B taken along line A-A. In various embodiments, such as when themigration reduction feature 100 can be located on the non-applicatorfacing surface 102 of the supporting arms 28, the migration reductionfeature 100 can be placed at any distance 104 from the supporting tips32 as deemed suitable for the core 12 to interact with the inner surfaceof the housing 42 of an applicator 40 to prevent or minimize migrationof the vaginal insert 10 within the housing 42 of an applicator 40. Invarious embodiments, the distance 104 from the supporting tip 32 to thetrailing surface 106 (illustrated in FIG. 18E) of the migrationreduction feature 100 can be from about 13, 14, or 15 mm to about 16,17, or 18 mm.

FIG. 18D provides a cross-sectional view of the core 12 of FIG. 18Ctaking along line B-B. As can be seen in the illustration provided, themigration reduction feature 100 can extend from the non-applicatorsurface 102 of the supporting arm 28. The migration reduction feature100, as illustrated, can have five sides, such as sides, 110, 112, 114,116, and 118. Side 110 can abut the non-applicator facing surface 102 ofthe core 12, sides 112 and 118 can extend perpendicular to thenon-applicator facing surface 102 of the core 12, and sides 114 and 116can extend diagonally from sides 112 and 118, wherein sides 114 and 116converge towards each other until joining at apex 120. A trailingsurface 106 (illustrated in FIG. 18E) can extend between and connect toeach of sides 110, 112, 114, 116, and 118, and the apex 120. A leadingsurface 108 can extend between and connect to each of sides 110, 112,and 118. In various embodiments, the leading surface 108 can also extendbetween and connect to sides 114 and 116 and apex 120 in addition toextending between and connecting sides 110, 112 and 118 (such as can beillustrated in FIG. 19D). In various embodiments, such as illustrated inFIG. 18E, the leading surface 108 can at least partially connect tosides 114 and 116 but does not fully connect to the apex 120. In suchembodiments, the migration reduction feature 100 can have an additionalside 122 which can be bounded by edges 124 and a pair of additionaledges 126 (one of which is visible in FIG. 18E). Edge 124 can join sides108 and 122 and the pair of edges 126 can converge towards each otherand meet with apex 120.

As illustrated in FIG. 18D, the sides 114 and 116 can converge at apex120. The angle at which the two sides 114 and 116 converge towards eachother can be any angle as deemed suitable. In various embodiments, theangle of convergence 128 of sides 114 and 116 can be about 90°. Themigration reduction feature 100 can have an overall length 130, anoverall width 132, and an overall height 134. The overall length 130 canbe the length from the apex 120 to the side 110 which abuts thenon-applicator facing surface 102 of the supporting arm. In variousembodiments, the overall length 130 of the migration reduction feature100 can be from about 1, 2 or 3 mm to about 4, 5, 6 or 7 mm. The overallwidth 132 of the migration reduction feature 100 can be the widthbetween sides 112 and 118. In various embodiments, the overall width 132can be from about 1, 2, 3, 4 or 5 mm to about 6 or 7 mm. The overallheight 134 can be the distance extending from the leading surface 108 tothe trailing surface 106. In various embodiments, the overall height 134of the migration reduction feature 100 an be from about 1, 2, 3 or 4 mmto about 5, 6 or 7 mm.

As a non-limiting example, in various embodiments, a core 12 can be madeaccording to the design illustrated in FIGS. 18A-18E and can have thefollowing configuration: The core 12 can be manufactured from a softsilicone polymer and can have a Shore A hardness of 50. The core 12 canhave an anchoring element 18, a supporting element 20, and a node 22located between the anchoring element 18 and the supporting element 20.In the radially expanded configuration, the anchoring element 18 of thecore 12 can have a diameter 92 of about 32 mm±1 mm, the supportingelement 20 can have a diameter 94 of about 41 mm±1 mm, and the length 96of the core 12 can be about 42 mm±1 mm. The core 12 can include amigration reduction feature 100 located on the non-applicator facingsurface 102 of each of the supporting arms 28 of the supporting element20. The migration reduction feature 100 can be located a distance 104 ofabout 14.5 mm from the supporting tip 32 to the trailing surface 106 ofthe migration reduction feature 100. The migration reduction feature 100can have a leading surface 108 and a trailing surface 106 and an overallheight 134 of about 5 mm. The trailing surface 106 can extend betweenand connect sides, 110, 112, 114, 116, and 118. Side 110 can abut thenon-applicator facing surface 102 and sides 114 and 116 can convergetowards each other, with an angle of convergence 128 of about 90°, andconverge until joining at apex 120. The leading surface 108 can extendbetween and connect sides 110, 112 and 118 and can partially extendbetween and connect sides 114 and 116. The migration reduction feature100 can have an additional side 122 which can be bounded by edge 124 andthe pair of edges 126 which can converge until reaching the apex 120.The overall length 130 of the migration reduction feature 100 can beabout 4.5 mm and the overall width 132 of the migration reduction 100feature can be about 6 mm.

In various embodiments, a core 12 can have a migration reduction feature70 extending from an applicator facing surface 80 of the core 12 and amigration reduction feature 100 extending from a non-applicator facingsurface 102 of the core 12. In such embodiments, the migration reductionfeature 70 can be as described herein in relation to FIGS. 17A-17D. Insuch embodiments, the migration reduction feature 100 can be asdescribed herein in relation to FIGS. 18A-18E. Referring to FIGS.19A-19F, a non-limiting example of an embodiment of a core 12 having atleast one migration reduction feature 70 located on an applicator facingsurface 80 and at least one migration reduction feature 100 located on anon-applicator facing surface 102 can be illustrated. FIG. 19A and FIG.19B can provide a perspective view and a side view, respectively, ofsuch a core 12 having at least one migration reduction feature 70located on an applicator facing surface 80 and at least one migrationreduction feature 100 located on a non-applicator facing surface 102.FIG. 19C can provide a bottom view of the core 12 and the migrationreduction feature 100 extending from the non-applicator facing surface102 of the core 12. FIG. 19D can provide a cross-section view of thecore 12 as illustrated in FIG. 19B and taken along line A-A. FIG. 19Ecan provide a cross-sectional view of the core 12 illustrated in FIG.19D and taken along line B-B. FIG. 19F can provide a close-up view ofArea C of the core 12 illustrated in FIG. 19D.

As a non-limiting example, in various embodiments, a core 12 can be madeaccording to the design illustrated in FIGS. 19A-19F and can have thefollowing configuration: The core 12 can be manufactured from a softsilicone polymer and can have a Shore A hardness of 50. The core 12 canhave an anchoring element 18, a supporting element 20, and a node 22located between the anchoring element 18 and the supporting element 20.In the radially expanded configuration, the anchoring element 18 of thecore 12 can have a diameter 92 of about 32 mm±1 mm, the supportingelement 20 can have a diameter 94 of about 50 mm±1 mm, and the length 96of the core 12 can be about 37 mm±2 mm. The core 12 can include amigration reduction feature 70 located on the applicator facing surface80 of each of the supporting arms 28 of the supporting element 20. Themigration reduction feature 70 can have a leading end 74 and a trailingend 76 and can have an overall length 84 of about 3 mm from the leadingend 74 to the trailing end 76. The distance 72 from the supporting tip32 to the trailing end 76 can be about 16 mm. The migration reductionfeature 70 can include a divot 78, thereby producing two ridges, 88 and90. The divot 78 can be positioned closer to the leading end 74 of themigration reduction feature 70 and the length 86 between the divot 78and the trailing end 76 can be more than half of the overall length 84of the migration reduction feature 70. In this example, the length fromthe divot 78 to the trailing end 76 can be about 2 mm. Each of theridges, 88 and 90, can extend from the applicator facing surface 80 ofthe core 12 to substantially the same height 82 and such height 82 ofeach ridge can be about 0.50 mm±0.05 mm. The core 12 can include amigration reduction feature 100 located on the non-applicator facingsurface 102 of each of the supporting arms 28 of the supporting element20. The migration reduction feature 100 can be located a distance 104 ofabout 16 mm from the supporting tip 32 to the trailing surface 106 ofthe migration reduction feature 100. The migration reduction feature 100can have a leading surface 108 and a trailing surface 106 and an overallheight 134 of about 5 mm. The leading surface 108 and the trailingsurface 106 can extend between and connect sides, 110, 112, 114, 116,and 118. Side 110 can abut the non-applicator facing surface 102 andsides 114 and 116 can converge towards each other, with an angle ofconvergence 128 of about 90°, and converge until joining at apex 120.The overall length 130 of the migration reduction feature 100 can beabout 5 mm and the overall width 132 of the migration reduction feature100 can be about 6 mm.

In various embodiments, a core 12 can be designed as deemed suitable. Asdescribed herein, a core 12 can have an anchoring element 18, asupporting element 20, and a node 22 connecting the anchoring element 18and the supporting element 20. The core 12 can be designed in a varietyof sizes wherein the difference between one size of a core 12 andanother size of a core 12 can be in any one of the following: thediameter 92 of the anchoring element 18 when in a radially expandedconfiguration; the diameter 94 of the supporting element 20 when in aradially expanded configuration; the length 96 of the core 12 when thecore 12 is in an expanded configuration; the Shore A hardness of thecore 12; the presence, if desired, of a migration reduction feature 70on an applicator facing surface 80 of the core 12; the presence, ifdesired, of a migration reduction feature 100 on a non-applicator facingsurface 102 of the core 12.

In various embodiments, a core 12 can be designed as deemed suitable andcan have an anchoring element 18 which can have a diameter from about 30to about 33 mm when in a radially expanded configuration; a supportingelement 20 which can have a diameter from about 34 to about 52 mm whenin a radially expanded configuration; a length from about 34 to about 46mm when in an expanded configuration; a Shore A hardness from 30-80;optionally, a migration reduction feature 70 positioned on an applicatorfacing surface 80 of the core 12; optionally, a migration reductionfeature 100 positioned on a non-applicator facing surface 102 of thecore 12; optionally, both of a migration reduction feature 70 positionedon an applicator facing surface 80 of the core 12 and a migrationreduction feature 100 positioned on a non-applicator facing surface 102of the core 12. In such various embodiments wherein a migrationreduction feature, such as migration reduction features 70 and/or 100,are located on the core 12, the number of, size of and placement of suchmigration reduction features can be designed as deemed suitable. Invarious embodiments, the length 84 of a migration reduction feature 70can be from about 2.0 mm to about 6.0 mm and the height 82 of amigration reduction feature 70 can be from about 0.02 mm to about 1.60mm. In various embodiments, the length 130 of a migration reductionfeature 100 can be from about 1 to about 7 mm; the width 132 of amigration reduction feature 100 can be from about 1 to about 7 mm; theheight 134 of a migration reduction feature 100 can be from about 1 toabout 7 mm.

In various embodiments, an array of at least two vaginal inserts 10which can have different sizes of cores 12 can be provided. A woman mayfind such an array in a single common outer package or one vaginalinsert 10 with one size of core 12 may be in a first package and avaginal insert 10 with a different size of core 12 may be in a secondpackage, and the two packages may be located in the vicinity of eachother, such as in the same shopping aisle of a store. In variousembodiments, the array of vaginal inserts 10 can have at least onevaginal insert 10 having one size of core 12 with at least one migrationreduction feature (70 and/or 100) and another vaginal insert 10 having adifferent size of core 12 with at least one migration reduction feature(70 and/or 100). In such embodiments, the sizes of cores 12 can differfrom each other in at least one of, for example, exhibiting a differentperformance characteristic, material hardness, operational dimension,weight, overall diameter of the supporting element 20 of the core 12when the supporting arms 28 are radially expanded, and/or the radialspread angle at which the supporting arms 28 protrude outwardly relativeto the longitudinal axis 24 of the core 12 and/or type of migrationreduction feature.

In the interests of brevity and conciseness, any ranges of values setforth in this disclosure contemplate all values within the range and areto be construed as support for claims reciting any sub-ranges havingendpoints which are whole number values within the specified range inquestion. By way of hypothetical example, a disclosure of a range offrom 1 to 5 shall be considered to support claims to any of thefollowing ranges: 1 to 5; 1 to 4; 1 to 3; 1 to 2; 2 to 5; 2 to 4; 2 to3; 3 to 5; 3 to 4; and 4 to 5.

The dimensions and values disclosed herein are not to be understood asbeing strictly limited to the exact numerical values recited. Instead,unless otherwise specified, each such dimension is intended to mean boththe recited value and a functionally equivalent range surrounding thatvalue. For example, a dimension disclosed as “40 mm” is intended to mean“about 40 mm.”

All documents cited in the Detailed Description are, in relevant part,incorporated herein by reference; the citation of any document is not tobe construed as an admission that it is prior art with respect to thepresent invention. To the extent that any meaning or definition of aterm in this written document conflicts with any meaning or definitionof the term in a document incorporated by references, the meaning ordefinition assigned to the term in this written document shall govern.

While particular embodiments of the present invention have beenillustrated and described, it would be obvious to those skilled in theart that various other changes and modifications can be made withoutdeparting from the spirit and scope of the invention. It is thereforeintended to cover in the appended claims all such changes andmodifications that are within the scope of this invention.

What is claimed is:
 1. A vaginal insert comprising an anchoring element,a supporting element, a node between the anchoring element and thesupporting element, and a first migration reduction feature.
 2. Thevaginal insert of claim 1 wherein the first migration reduction featureis located on a first supporting arm of the supporting element.
 3. Thevaginal insert of claim 2 wherein the first migration reduction featureis located on an applicator facing surface of the first supporting armof the supporting element.
 4. The vaginal insert of claim 2 wherein thefirst migration reduction feature is located on a non-applicator facingsurface of the first supporting arm of the supporting element.
 5. Thevaginal insert of claim 2 further comprising a second migrationreduction feature located on the first supporting arm of the supportingelement.
 6. The vaginal insert of claim 5 wherein the second migrationreduction feature is located on an applicator facing surface of thefirst supporting arm of the supporting element.
 7. The vaginal insert ofclaim 5 wherein the second migration reduction feature is located on anon-application facing surface of the first supporting arm of thesupporting element.
 8. The vaginal insert of claim 2 further comprisinga second migration reduction feature located on a second supporting armof the supporting element.
 9. The vaginal insert of claim 8 wherein thesecond migration reduction feature is located on an applicator facingsurface of the second supporting arm of the supporting element.
 10. Thevaginal insert of claim 8 wherein the second migration reduction featureis located on a non-applicator facing surface of the second supportingarm of the supporting element.
 11. The vaginal insert of claim 1 whereinthe first migration reduction feature is located on a first anchoringarm of the anchoring element.
 12. The vaginal insert of claim 11 whereinthe first migration reduction feature is located on an applicator facingsurface of the first anchoring arm of the anchoring element.
 13. Thevaginal insert of claim 11 wherein the first migration reduction featureis located on a non-applicator facing surface of the first anchoring armof the anchoring element.
 14. An array of vaginal inserts comprising: a.a first vaginal insert comprising an anchoring element, a supportingelement, a node between the anchoring element and the supportingelement, a first migration reduction feature and a Shore A hardness; b.a second vaginal insert comprising an anchoring element, a supportingelement, a node between the anchoring element and the supportingelement, a first migration reduction feature and a Shore A hardness;wherein the second vaginal insert differs from the first vaginal insertin at least one of the Shore A hardness or the migration reductionfeature.
 15. The array of claim 14 wherein the Shore A hardness of thesecond vaginal insert differs from the Shore A hardness of the firstvaginal insert.
 16. The array of claim 14 wherein the first migrationreduction feature of the second vaginal insert differs from the firstmigration reduction feature of the first vaginal insert.
 17. The arrayof claim 14 wherein the first migration reduction feature of the firstvaginal insert is located on a first supporting arm of the supportingelement of the first vaginal insert and the first migration reductionfeature of the second vaginal insert is located on a first supportingarm of the supporting element of the second vaginal insert.
 18. Thearray of claim 17 wherein the first migration reduction feature of thefirst vaginal insert is located on an applicator facing surface of thefirst supporting arm of the first vaginal insert and the first migrationreduction feature of the second vaginal insert is located on anon-applicator facing surface of the first supporting arm of the secondvaginal insert.